- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04939844
REST - Replacing Steroids in the Transplant Ineligble (REST)
Isatuximab in Combination With Bortezomib and Lenalidomide With Minimal Dexamethasone in Transplant-ineligible Multiple Myeloma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Frida B Askeland, MD
- Phone Number: +4799013348
- Email: friask@ous-hf.no
Study Contact Backup
- Name: Anna Lysen
- Phone Number: +4723016063
- Email: annaly@ous-hf.no
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
- Voluntary written informed consent.
- Participant must be >18 years of age at the time of signing the informed consent.
- Newly diagnosed multiple myeloma (IMWG criteria) in-eligible for high-dose therapy and ASCT.
Measurable disease as defined by the International Myeloma Working Group:
- Serum monoclonal paraprotein (M-protein) level > 10 g/L or urine M-protein level >200 mg/24 hours; or
- Light chain multiple myeloma without measurable disease in the serum or the urine: Involved serum immunoglobulin FLC > 100 mg/L and abnormal serum immunoglobulin kappa lambda FLC ratio.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. ECOG 3 can only be enrolled if caused by myeloma.
Clinical laboratory values meeting the following criteria during the Screening Phase:
a. Adequate bone marrow function:
- Hemoglobin >7,5 g/dL (transfusion is permitted, recombinant human EPO use is permitted, however transfusion is not permitted within 3 days before screening)
- Absolute neutrophil count > 1.0 x 109/L (G-CSF use is permitted)
Platelet count >70 x 109/L
a) Adequate renal function:
- eGFR>30 mL/min/m2
- Patient must be willing and able to adhere to the study protocol visit schedule and other protocol requirements.
- Females of childbearing potential (FCBPs) must have a confirmed negative serum or urine pregnancy test within 10-14 days prior to and again within 24 hours prior to starting study medication.
- FCBPs and male subjects who are sexually active with FCBP must agree to use highly effective concomitant methods of contraceptive during the intervention period, for at least 5 months after last dose of isatuximab treatment and at least 28 days after last lenalidomide treatment. Male subjects must refrain from donating sperm during this period.
Exclusion Criteria:
- Prior or current systemic therapy for multiple myeloma with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.
- Radiation therapy for treatment of plasmacytoma(s) within 14 days before treatment (local radiation for pain control or to prevent fracture is allowed within 14 days before treatment).
- Active hepatitis B or C virus infection or known human immunodeficiency virus (HIV) positivity.
- Any other serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- No active malignancy with a lower life expectancy than myeloma.
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NDMM ineligible for transplant
All participants will receive isatuximab in combination with bortezomib, lenalidomide and dexamethasone for 2 cycles, followed by isatuximab in combination with bortezomib and lenalidomide for 6 cycles, followed by isatuximab in combination with lenalidomide for 10 cycles, followed by continuous lenalidomide until disease progression. The cycle duration is 28 days.
|
All participants will receive the same treatment as described under arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MRD negativity
Time Frame: 34 months
|
The proportion of patients who achieve MRD negativity measured by NGF Euroflow during and/or after 18 cycles of study treatment.
|
34 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: 30 months
|
The proportion of patients who achieve partial response (PR) or better following 18 cycles of study treatment
|
30 months
|
Progression free survival
Time Frame: 4 years
|
The PFS rate of patients receiving 2 cycles of IVRd followed by 6 cycles of IVR, 10 cycles of IR and continuous R
|
4 years
|
Overall survival
Time Frame: 5 years
|
The OS rate of patients receiving 2 cycles of IVRd followed by 6 cycles of IVR, 10 cycles of IR and continuous R.
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fredrik H Schjesvold, MD, PhD, Oslo University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
- Bortezomib
Other Study ID Numbers
- OMC02/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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